FDA Approves Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
December 1, 2022 -- On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rebyota (fecal microbiota, live-jslm) Microbiota-Based Live Biotherapeutic for the Prevention of Recurrence of Clostridioides Difficile Infection
Ferring’s novel first-in-class Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI The safety and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 30, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B
This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion With... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 22, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sezaby (phenobarbital sodium powder for injection) for the Treatment of Neonatal Seizures
First and only product approved for treating seizures in neonatal patients Mumbai, India, November 18, 2022– Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 18, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes
Tzield is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients, Tzield delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 17, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Medicines360 ’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years
SAN FRANCISCO– Nov. 14, 2022 -- Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 14, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Elahere (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
Elahere is the First ADC Approved by FDA for Platinum-Resistant Ovarian Cancer Indication Covers Patients with One to Three Prior Systemic Treatment Regimens, Regardless of Prior Avastin® Use VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 14, 2022 Category: Drugs & Pharmacology Source Type: news

Imfinzi and Imjudo with Chemotherapy Approved in the US for Patients with Metastatic Non-Small Cell Lung Cancer
Approval based on POSEIDON Phase III trial results, which showed significant survival benefit with a limited course of Imjudo added to Imfinzi and chemotherapy 11 November 2022 -- AstraZeneca’s Imfinzi (durvalumab) in combination with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 11, 2022 Category: Drugs & Pharmacology Source Type: news

Seagen Announces U.S. FDA Approval of New Indication for Adcetris (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma
Approval Based on Phase 3 Clinical Study That Demonstrated a 59% Reduction in Risk of Disease Progression or Relapse, Second Malignancy or Death vs. Standard of Care BOTHELL, Wash.--(BUSINESS WIRE) November 10, 2022 --Seagen Inc. (Nasdaq: SGEN)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2022 Category: Drugs & Pharmacology Source Type: news

Libtayo (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)
Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide range of disease characteristics Second advanced NSCLC indication expands patient population eligible... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 8, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Fully Liquid Presentation of GSK ’s Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus
New fully liquid formulation of Rotarix removes the need to reconstitute prior to administration, for improved convenience Clinical data demonstrated non-inferiority of immunogenicity as compared to the lyophilized formulation of Rotarix and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 7, 2022 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves Vemlidy (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients
Approval Expands on Previous FDA Approval of Vemlidy in Adults Living With This Chronic Liver Disease Efficacy and Safety of Once-Daily Vemlidy Demonstrated in Individuals 12 Years of Age and Older FOSTER CITY, Calif.--(BUSINESS WIRE) November... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 2, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tecvayli (teclistamab-cqyv) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Tecvayli, an off-the-shelf, subcutaneous therapy, is an important new medicine for patients with incurable blood cancer who face limited treatment options HORSHAM, Pa., October 25, 2022– The Janssen Pharmaceutical Companies of Johnson... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 25, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imjudo (tremelimumab) in Combination with Imfinzi for Patients with Unresectable Hepatocellular Carcinoma
24 October 2022 -- AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 24, 2022 Category: Drugs & Pharmacology Source Type: news

Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis
Rinvoq is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) Rinvoq is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 21, 2022 Category: Drugs & Pharmacology Source Type: news